Quality

CTTI Releases New Recommendations & Toolkit to Help Organizations Implement Quality by Design

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) has issued recommendations to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.

Recognizing that time and resources are finite, CTTI encourages sponsors to build quality into the scientific and operational design and conduct of a clinical trial. CTTI defines “quality” in clinical trials as the absence of errors that matter to decision making–that is, errors which have a meaningful impact on the safety of trial participants or reliability of the results (and thereby the care of future patients).

“CTTI’s recommendations put the patient perspective at the center of the process by proactively identifying and managing those aspects of clinical trials most likely to negatively impact trial participants. Patient advocates readily understand the need to focus on errors that matter rather than spreading effort and attention thinly across all potential errors,” said Nancy Roach, founder and chair of the board of Fight Colorectal Cancer.

CTTI recommends sponsors create a culture that values and rewards critical thinking and open dialogue about quality, and that goes beyond sole reliance on tools and checklists; focus effort on activities that are essential to the credibility of the study outcomes; involve the broad range of stakeholders in protocol development and discussions around study quality; and prospectively identify and periodically review the critical to quality factors.

A toolkit is available to help sponsors implement the recommendations. Included in the toolkit are resources that can facilitate proactive, cross-functional dialogue and decision-making about trial design and planning. For example, the Critical to Quality Factors document can help sponsors to focus on the critical to quality factors when designing clinical trial protocols. The critical to quality factors are not intended to be a simple check-list but to stimulate discussion and prioritization of the most critical determinants of a trial’s quality and formulation of an appropriate plan to define, avoid, mitigate, monitor and address important and likely risks to study quality.

“CTTI’s recommendations emphasize the importance of prospectively building quality into the scientific and operational design of clinical trials, rather than relying only on retrospective monitoring, inspection or scientific review. This systematic, proactive, and focused approach is compatible with FDA guidance on risk-based monitoring,” noted Robert Temple, M.D., Deputy Center Director for Clinical Science at the U.S. Food and Drug Administration (FDA).

The recommendations and toolkit have been formally unveiled during a presentation at the DIA annual meeting.

*For a link to a PDF of this press release, click here.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 3)

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning, where quality is defined as the absence of errors that matter to decision-making. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The third and final webinar in this series recently took place on April 15, 2015, featuring speakers from Johnson & Johnson and the University of Oxford who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here.

To view a recording of the second webinar in this series, click here.

Mark your calendars for 12:00 PM EST on July 16, 2015! CTTI will be hosting a public QbD webinar to unveil our QbD toolkit. The QbD Toolkit will provide users with resources for:

  1. Promoting QbD concepts in their organization,
  2. Educating colleagues about QbD concepts via case studies, and
  3. Implementing QbD in real trials.

From Theory to Practice: Advancing QbD in Clinical Trials at Upcoming Partnerships in Clinical Trials Conference

Posted on by Lorri Bingham

Quality by Design (QbD) emphasizes building quality into a process from the beginning. While a broad cross-section of key stakeholders in the clinical trials enterprise agree that the widespread adoption of an enlightened QbD approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency, a lack of real-world examples of this process leave many wondering how to move from theory to practice.

To help answer these questions, two members of CTTI’s QbD Project will be presenting at the 24th Annual Partnerships in Clinical Trials Meeting in Boston, MA on April 24, 2015:

Session Title: Clinical Quality by Design – Principles to Practice

Speakers:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, Johnson & Johnson Quality and Compliance
  • Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer

Agenda:

  • Develop understanding of Quality by Design (QbD) principles for clinical trials
  • Identify perceived barriers and potential solutions to the adoption of Quality by Design
  • Review opportunities for dissemination of these principles and practices to a broad array of stakeholders

We look forward to connecting with our colleagues at #PCTUS.

If you are interested in hearing more stories of translating QbD principles into practice, please join us during a one-hour CTTI-hosted webinar on April 15.

Updated AACT Database Now Available on the CTTI Website, New Features Included

Posted on by Lorri Bingham

CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in September 2014. To assist users with interpretation of the data, high level and comprehensive data dictionaries and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.

We are pleased to announce that new features to assist usability accompany the most recent AACT Database. Please see the Points to Consider Document for more details. These features include:

  • An additional “readme” document is included in the pipe-delimited text files zip file for users who plan to work with the data extracts in the R statistical computing environment.
  • A target duration (e.g. 180 Days) variable is now included for records where the STUDY_TYPE=”Observational [Patient Registry]”.
  • New “Delayed Results” data elements are included in the pipe-delimited text files and SAS CPORT transport files. This includes a list of studies, provided by the National Library of Medicine, that had submitted a certification or extension request to the 12-month results reporting requirement before September 27, 2014, and the date of the first certification or extension request. For further details, refer to the “readme” documents within the zip files.

Since CTTI released the first AACT database, it has been utilized to answer many questions regarding the landscape of clinical trials. For a list of peer-reviewed publications that have assessed the state of trials within medical specialties, CLICK HERE.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 2)

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The second webinar in this series recently took place on January 14, 2015 and featured speakers from The Medicines Company and AstraZeneca who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here. The final webinar in this series is scheduled for Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST.

CTTI Webinar Provides Real-World Examples of Quality by Design (QbD) in Clinical Trials (Part 2)

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. (Click here to view the first webinar in this series.)

Topic: Translating Quality by Design Principles into Practice, Part 2

Date: Wednesday, January 14, 2015

Time: 11:00 a.m. – 12:00 p.m. Eastern Standard Time (New York, GMT-05:00)

Agenda:

  • CTTI QbD Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical QA Strategy, Janssen
  • Quality Management in Clinical Trials: Keeping it Simple by Sabrina Comic-Savic, MD, MPH Senior Director, GCP Compliance, The Medicines Company
  • QbD – An Example from a Running CV Outcome Trial by Helene DuPui-Ekdal Director, Clinical Development, AstraZeneca
  • Q & A

THIS WEBINAR IS OPEN TO THE PUBLIC. WE ENCOURAGE YOU TO FORWARD THIS INVITATION TO OTHERS WHO MAY BE INTERESTED IN LEARNING MORE ABOUT QBD IMPLEMENTATION.

To join the webinar on January 14, go to:
https://dukemed.webex.com/dukemed/j.php?MTID=m6674f0b144ed076e5afb9322a67442d9
Meeting Number: 738 965 414
Meeting Password: ctti

If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)

The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

Mark your calendars. The QbD Webinar Series will continue on the following date:

Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)

CTTI’s Tools for Improving Clinical Trial Quality & Efficiency

Posted on by Lorri Bingham

In our pursuit to enhance the implementation of CTTI’s recommendations, we’ve created a new webpage on our site that we’d like to share with you. This page features CTTI’s three most commonly used tools:

  1. The Considerations Document for a Single IRB of Record: Developed by CTTI’s Central IRB Project, this tool supports communication and contractual relationships between institutions and a central IRB to address blurred distinctions between responsibilities for ethics review and other institutional obligations. Primary users for this tool include sponsors, academic institutions, investigators, IRBs that act as a single IRB of record.
  2. The Quality by Design Principles Document: Developed by CTTI’s QbD Project, this tool helps those working in trials to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. Primary users for this tool include anyone interested in designing and conducting clinical trials.
  3. The AACT Database: Developed by CTTI’s State of Clinical Trials Project, this tool makes the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Primary users for this tool include researchers interested in analyzing data from clinical trials.

The Tools Page can be accessed on the CTTI site under Briefing Room > Tools. We hope that you find this resource valuable and share with your colleagues in the clinical trials enterprise.

CTTI Among the Spotlighted Consortia Focused on Drug Development Challenges

Posted on by Lorri Bingham

The latest issue of Nature Reviews Drug Discovery highlights several consortia that have resulted from the FDA’s Critical Path Initiative, launched nearly a decade ago. CTTI is among these initiatives and was featured in the article, The Clinical Trials Transformation Initiative: innovation through collaboration.

This publication explains the crisis in the clinical trials enterprise and CTTI’s unique role in developing actionable solutions. Several CTTI project are highlighted, including Quality by Design, Central IRB, and Investigational New Drug Safety Reporting. For each of these projects, the authors identify the issue at hand and go on to explain CTTI’s efforts to implement recommendations, noting both the difficulties and imperative of creating cultural and organizational change. The authors also comment on the ability of CTTI’s evidence-based work to inform policy and practices in the interest of public health.

“By creating an environment of trust, we enable the stakeholders — representing all sectors of the enterprise — to think about practical solutions to the identified problems and to develop strategies to effect change.”
– Pamela Tenaerts, Leanne Madre, Patrick Archdeacon, and Robert Califf